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Full Prescribing Information
INDICATIONS FOR USE
The Biomet®OrthoPak®Non-invasive Bone Growth Stimulator System is indicated for the treatment of an
established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width
of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to
be established when the fracture site shows no visible progressive signs of healing.
The original approval was based on a PMA Study, which included 69 patients with efficacy of 72.5%. An
additional cohort of 21 recalcitrant patients with multiple prior procedures and unsuccessful electrical
stimulation with different modality was added and yielded efficacy of 33.3%. Seventy-nine patients out of
90 treated had at least 4 years follow-up after the date of treatment termination for a follow-up rate of 88%.
The follow-up results were 45 patients healed; four previously healed patients have died; three patients,
who were “healing” at the end of treatment, were healed with additional treatment. Counting only the 45
unconditionally healed patients, the efficacy at 4 year follow-up was 50%. A subsequent survey of 295
patients conducted from March 1988 to September 1990 by an independent agency, yielded an efficacy
of 73.2%.
CONTRAINDICATION:
The use of this device is contraindicated if the individual has synovial pseudarthrosis.
WARNINGS:
• Utilization of this stimulator allows full weight bearing on the casted extremity unless gross motion
(greater than 5 degrees in any plane) at the nonunion site is present. In such a case, weight bearing is
not advised and should not be permitted as this may compromise the effectiveness of the treatment.
The safety and effectiveness of the use of the device on individuals lacking skeletal maturity has not
been established.
• In the presence of a maligned nonunion, careful consideration on the use of this device must be
undertaken on an individual basis, as treatment with this device is not yet intended to alter or affect the
degree of malalignment.
• The amplitude of the treatment current must be between 5 and 10 milliamperes RMS. Treatment with this
device is not recommended on patients whose electrical impedance of the tissue between the electrodes
will not allow the device to operate within the prescribed 5 to 10 milliamperes range. The safety and
effectiveness of the use of this device on individuals with nonunion secondary to, or in conjunction with,
a pathological condition has not been established.
• Animal studies conducted to date indicate that the Biomet®OrthoPak®Non-invasive Bone Growth
Stimulator System does not interfere with the normal intrinsic activity of the heart. However, the
stimulator does interfere with the operation of certain pacemakers. The concomitant use of the device and
a pacemaker must be assessed on an individual basis, prior to use (such as with an electrocardiogram).
• Animal studies conducted to date do not suggest any long term adverse effects from use of this device.
However, long term effects in humans are unknown. Do not use this device beyond the prescribed
treatment period. General tissue sensitivity at the skin/electrode site with unknown specific etiology may
occur. This tissue sensitivity may be caused by the electrode gel, excess perspiration or a combination
of both. Such a reaction generally resolves spontaneously following diagnosis and correction of the
underlying cause.